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Job Description
Location: Pune, Maharashtra, India (Remote)
Job Type: Full-time
Organization: Syneos Health
Experience Required: Minimum 1 year (Clinical Trial Disclosure/CTT)
About the Role
Syneos Health is looking for a Medical Writer I (CTT) to join its global team of experts driving innovation in biopharmaceutical development. The role involves creating, editing, and coordinating high-quality clinical and regulatory documents that support clinical trials and submissions.
This position is ideal for professionals passionate about scientific writing, clinical data accuracy, and regulatory documentation, who want to grow in a global, collaborative environment dedicated to accelerating patient-focused healthcare outcomes.
Role & Responsibilities
- Serve as a medical writer on clinical study and regulatory project teams under moderate supervision.
- Develop, edit, and review key clinical and regulatory documents, including:
- Clinical Study Protocols and Amendments
- Clinical Study Reports (CSRs)
- Patient Narratives
- Investigator’s Brochures
- Clinical Study Protocols and Amendments
- Conduct protocol and result registration, as well as results posting for regulatory bodies.
- Review statistical analysis plans, tables, figures, and listings for content accuracy, format, and consistency.
- Collaborate with cross-functional departments such as Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs.
- Perform literature searches and ensure adherence to ICH-E3 guidelines, company SOPs, and client standards.
- Manage multiple writing assignments while maintaining quality, accuracy, and compliance within project timelines and budgets.
- Stay updated with regulatory guidance, industry best practices, and new client expectations affecting medical writing.
- Complete administrative tasks and project deliverables within specified timelines.
Educational Qualification
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or related field.
- Minimum of 1 year of experience in Clinical Trial Disclosure (CTT) or medical writing.
- Understanding of clinical research processes, regulatory documentation, and ICH-GCP standards.
Location
Pune, Maharashtra, India (Remote)
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